Unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC).
Pre- and post-menopausal women age ≥ 18 years with unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC) with no prior line of chemotherapy in the metastatic setting, and that have shown progression while on an aromatase inhibitor-containing regimen in the metastatic setting or within six months from last aromatase inhibitor dose in the adjuvant setting. Patients must have received at least one taxane or anthracycline regimen in either the adjuvant or the neoadjuvant setting. Subjects must have adequate bone marrow and creatinine clearance functions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Patients will receive eribulin injections intravenously on days 1 and 8 of every 21-day cycle alone.
Hospital de Jaén
Jaén, Jaén, Spain
Hospital Quiron Dexeus
Barcelona, Please Select, Spain
Institut Català d'Oncologia
Girona, Spain
Complejo Asistencial Universitario de León
León, Spain
The overall response rate (ORR)
The overall response rate (ORR) in the eribulin + ET arms, defined as the proportion of patients with best overall response of confirmed complete response or partial response based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.
Time frame: Baseline up to 27 months
The progression-free survival (PFS)
The progression-free survival (PFS) for patients treated with endocrine therapy alone or in combination with eribulin is defined as the time from randomization until death by any cause or objective tumor progression based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.
Time frame: Baseline up to 27 months
PFS-2, in the eribulin and the eribulin + ET arms
The PFS-2, in the eribulin and the eribulin + ET arms, defined as the time from the randomization to the second disease progression or death, i.e., PFS after the next line of treatment, based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.
Time frame: Baseline up to 27 months
Overall response rate (ORR) in the eribulin arm
The overall response rate (ORR) in the eribulin arm, defined as the proportion of patients with best overall response of confirmed complete response or partial response based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.
Time frame: Baseline up to 27 months
The duration of response (DOR) in the eribulin and the eribulin + ET arms
The duration of response (DOR) in the eribulin and the eribulin + ET arms, defined as the time from the start of the treatment to disease progression based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.
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Hospital Ramón y Cajal
Madrid, Spain
Hospital Universitario La Paz,
Madrid, Spain
Hospital Son Llatzer
Palma de Mallorca, Spain
Hospital Universitario Dr Peset
Valencia, Spain
Hospital Miguel Servet
Zaragoza, Spain
Time frame: Baseline up to 27 months
The clinical benefit rate (CBR) in the eribulin and the eribulin + ET arms
The clinical benefit rate (CBR) in the eribulin and the eribulin + ET arms, defined as the proportion of patients with no disease progression after 6 months of therapy, based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.
Time frame: Baseline up to 27 months
The overall survival (OS) in the eribulin and the eribulin + ET arms
The overall survival (OS) in the eribulin and the eribulin + ET arms, defined as the length of time that patients remain alive from the start of treatment (OS will be collected at the end of the study).
Time frame: Baseline up to 27 months
Maximum Tumor shrinkage
Maximum Tumor shrinkage, defined as the percentage of tumor shrinkage from baseline (obtained from the sum of the largest diameters of the target lesions), based on local investigator's assessment according to RECIST criteria guidelines (version 1.1)1.
Time frame: Baseline up to 27 months